Glipizide

Product NDC: 12634-790
Requested package NDC: 12634-790-45
11-digit product format: 126340790
Labeler code: 12634
Product ID: 12634-790_463dc8c9-618d-0759-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA074550
Marketing category: ANDA
Marketing start: 2011-07-18
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 10 mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12634-790	12634-790-45	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074550-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL			1997-09-11
A074550-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL			1997-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL		1997-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL		1997-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074550-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	1997-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074550-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	1997-09-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A074550-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074550-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074550-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074550-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074550-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074550-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074550-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074550-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074550-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074550-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074550-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074550-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074550-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074550-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074550-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074550-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074550-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074550-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074550-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074550-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074550-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074550-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074550-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074550-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074550-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074550-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074550-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074550-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074550-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074550-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074550-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074550-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074550-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074550-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074550-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074550-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074550-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074550-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074550-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074550-002	AB	1	`a67488948f0b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09	Product name	2	20250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-790-00	GLIPIZIDE TABLETS, USP
12634-790-01	GLIPIZIDE TABLETS, USP
12634-790-09	GLIPIZIDE TABLETS, USP
12634-790-12	GLIPIZIDE TABLETS, USP
12634-790-18	GLIPIZIDE TABLETS, USP
12634-790-40	GLIPIZIDE TABLETS, USP
12634-790-42	GLIPIZIDE TABLETS, USP
12634-790-45	GLIPIZIDE TABLETS, USP
12634-790-50	GLIPIZIDE TABLETS, USP
12634-790-52	GLIPIZIDE TABLETS, USP
12634-790-54	GLIPIZIDE TABLETS, USP
12634-790-57	GLIPIZIDE TABLETS, USP
12634-790-59	GLIPIZIDE TABLETS, USP
12634-790-60	GLIPIZIDE TABLETS, USP
12634-790-61	GLIPIZIDE TABLETS, USP
12634-790-63	GLIPIZIDE TABLETS, USP
12634-790-66	GLIPIZIDE TABLETS, USP
12634-790-67	GLIPIZIDE TABLETS, USP
12634-790-69	GLIPIZIDE TABLETS, USP
12634-790-71	GLIPIZIDE TABLETS, USP
12634-790-74	GLIPIZIDE TABLETS, USP
12634-790-78	GLIPIZIDE TABLETS, USP
12634-790-79	GLIPIZIDE TABLETS, USP
12634-790-80	GLIPIZIDE TABLETS, USP
12634-790-81	GLIPIZIDE TABLETS, USP
12634-790-82	GLIPIZIDE TABLETS, USP
12634-790-84	GLIPIZIDE TABLETS, USP
12634-790-85	GLIPIZIDE TABLETS, USP
12634-790-90	GLIPIZIDE TABLETS, USP
12634-790-91	GLIPIZIDE TABLETS, USP
12634-790-92	GLIPIZIDE TABLETS, USP
12634-790-93	GLIPIZIDE TABLETS, USP
12634-790-94	GLIPIZIDE TABLETS, USP
12634-790-95	GLIPIZIDE TABLETS, USP
12634-790-96	GLIPIZIDE TABLETS, USP
12634-790-97	GLIPIZIDE TABLETS, USP
12634-790-98	GLIPIZIDE TABLETS, USP
12634-790-99	GLIPIZIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-790-00	Glipizide	10 in 1 BOTTLE	TABLET	10	1
12634-790-01	Glipizide	100 in 1 BOTTLE	TABLET	100	1
12634-790-09	Glipizide	35 in 1 BOTTLE	TABLET	35	1
12634-790-12	Glipizide	120 in 1 BOTTLE	TABLET	120	1
12634-790-18	Glipizide	180 in 1 BOTTLE	TABLET	180	1
12634-790-40	Glipizide	40 in 1 BOTTLE	TABLET	40	1
12634-790-42	Glipizide	42 in 1 BOTTLE	TABLET	42	1
12634-790-45	Glipizide	45 in 1 BOTTLE	TABLET	45	1
12634-790-50	Glipizide	50 in 1 BOTTLE	TABLET	50	1
12634-790-52	Glipizide	12 in 1 BLISTER PACK	TABLET	12	1
12634-790-54	Glipizide	14 in 1 BLISTER PACK	TABLET	14	1
12634-790-57	Glipizide	20 in 1 BLISTER PACK	TABLET	20	1
12634-790-59	Glipizide	30 in 1 BLISTER PACK	TABLET	30	1
12634-790-60	Glipizide	60 in 1 BOTTLE	TABLET	60	1
12634-790-61	Glipizide	10 in 1 BLISTER PACK	TABLET	10	1
12634-790-63	Glipizide	3 in 1 BLISTER PACK	TABLET	3	1
12634-790-66	Glipizide	6 in 1 BLISTER PACK	TABLET	6	1
12634-790-67	Glipizide	7 in 1 BLISTER PACK	TABLET	7	1
12634-790-69	Glipizide	9 in 1 BLISTER PACK	TABLET	9	1
12634-790-71	Glipizide	30 in 1 BOTTLE	TABLET	30	1
12634-790-74	Glipizide	24 in 1 BOTTLE	TABLET	24	1
12634-790-78	Glipizide	28 in 1 BOTTLE	TABLET	28	1
12634-790-79	Glipizide	25 in 1 BOTTLE	TABLET	25	1
12634-790-80	Glipizide	20 in 1 BOTTLE	TABLET	20	1
12634-790-81	Glipizide	21 in 1 BOTTLE	TABLET	21	1
12634-790-82	Glipizide	12 in 1 BOTTLE	TABLET	12	1
12634-790-84	Glipizide	14 in 1 BOTTLE	TABLET	14	1
12634-790-85	Glipizide	15 in 1 BOTTLE	TABLET	15	1
12634-790-90	Glipizide	90 in 1 BOTTLE	TABLET	90	1
12634-790-91	Glipizide	1 in 1 BLISTER PACK	TABLET	1	1
12634-790-92	Glipizide	2 in 1 BOTTLE	TABLET	2	1
12634-790-93	Glipizide	3 in 1 BOTTLE	TABLET	3	1
12634-790-94	Glipizide	4 in 1 BOTTLE	TABLET	4	1
12634-790-95	Glipizide	5 in 1 BOTTLE	TABLET	5	1
12634-790-96	Glipizide	6 in 1 BOTTLE	TABLET	6	1
12634-790-97	Glipizide	7 in 1 BOTTLE	TABLET	7	1
12634-790-98	Glipizide	8 in 1 BOTTLE	TABLET	8	1
12634-790-99	Glipizide	9 in 1 BOTTLE	TABLET	9	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-790	GLIPIZIDE TABLET [APOTHECA INC.]	1	Legacy NDC, 38 package rows	20170117_463df134-fe6d-5b08-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7WDT95N5C	GLIPIZIDE	29094-61-9	GLIPIZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310488	glipiZIDE 10 MG Oral Tablet	PSN	463df134-fe6d-5b08-e054-00144ff8d46c	1
310488	glipizide 10 MG Oral Tablet	SCD	463df134-fe6d-5b08-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12634-790-45	12634079045	45 TABLET in 1 BOTTLE (12634-790-45)	45 tablet	2011-07-18	0000-00-00	No	No	Current